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Registering your, Medical device
There are many stages involved with taking a medical device product from brilliant idea to a fully realised product which can be in the hands of patients or clinicians and having an impact on clinical outcomes. Once you’ve done all the hard work designing, developing and getting certification for your product, there’s still one last critical step; registering your medical device with the MHRA so you can finally put it on the UK market. This should be a fairly straightforward process, but it’s important to know what you’ll be expecting to see and what information you need to bring to the table.
Who should register a Medical device?
If you manufacture, refurbish or relabel any medical device, of any risk classification to sell into the UK, then you must register your medical device with the MHRA. This also applies to IVDs that you manufacture or ones you’re bringing into the UK for performance evaluation, and to any procedure pack which contains medical devices.
U.K based companies can register with the MHRA directly, and not doing so before putting medical devices onto the market will land you in legal trouble. If your company is based outside the UK, however, then you will need to appoint a “UK Responsible Person” (UKRP) for MHRA medical device registration. A UKRP is a single individual, based within the UK, who is responsible for contacting the MHRA on your behalf.
Need a UK Responsible Person?
We can help your team understand the requirements of medical devices, technical documentation and post-market surveillance for the UK and beyond.
DORS
Registration of devices with the MHRA, known as MHRA medical device registration, is done through their online portal “DORS” (Device Online Registration System), which you will need to make an account for.
The MHRA publishes and maintains a step-by-step guide on the fine details of how to sign up to the platform, including account creation and website navigation, but it’s up to you as the manufacturer to provide the appropriate information relating to your product.
Required Information
Once you’re set up in DORS, you will need to complete a comprehensive form, detailing your organisation, your product and how you’ve demonstrated that it conforms to the appropriate safety regulations for MHRA device registration.
This includes:
- What type of device is it? – Medical Device? IVD? Active implantable?
- What Global Medical Devices Nomenclature (GMDN) code does it belong to?
- Product name – this could be a brand name, a trade name, or a proprietary name
- Details about the version number or model number of the device you’re registering – if you have a lot of different versions ready to go, there’s a way to bulk upload a spreadsheet too
- Specific details and attributes surrounding product status – For example, is it sterile? Does it administer medicine? Etc.
- Who your approved body is (or your notified body if you have been through the EU MDR or IVDR conformity assessment).
- Copies of your conformity assessment certificates – whether that is a self-certification declaration of conformity or a UKCA or CE certificate.
You must also provide information about your organisation, such as the legal name, names of any contacts and the formal letter of designation which identifies your UKRP, if you’re a non-UK company.
How much does it cost?
Creating an account on the DORS platform is free, but fees apply for product registration.
As of the 16th July 2025, this fee is now £261. There may be additional fees if you need to make changes to your registration, such as updating your company name or the name of your UKRP. All relevant fees can be paid through DORS within the platform itself and should not be paid through an independent consultant.
This doesn’t account for the additional fees and costs that come with realising a medical device, including approved body auditing costs, clinical evaluations and the business impact of implementing regulatory oversight. The best way to make sure you plan for the financial impact of bringing a medical device to market is to understand your regulatory strategy at the very beginning. Our expert team can help.
Communicating with the MHRA
Communication with the MHRA doesn’t stop once you’ve registered your device through DORS. You are required to proactively review post-market surveillance data, looking for trends of issues which may be reportable and have a vigilance process, by which you must report any potentially hazardous events or problems related to your product directly to the MHRA. This is done through the MORE (Manufacturers On-line Reporting Environment) portal, another platform which you must sign up to.
The MORE portal is the centralised place to complete a range of web forms which form part of your vigilance reporting obligations under the medical device regulations.
These include:
- Manufacturer Incident Reports (MIR) – for reporting serious incidents
- Field Safety Corrective Actions (FSCAs) – for informing the public and regulators about in-field safety corrective actions
- Trend Reports – to report when the incidence of lower risk issues has gone above a significant threshold
And many more.
Access to the MORE portal is vital for fulfilling your vigilance and post-market obligations. The MHRA has published step-by-step guidance on how to register for and use the MORE portal.
Ready for the next steps?
Need help getting your product ready for registration with the MHRA or other regulators?
We can help your team understand the requirements of medical devices, technical documentation and post-market surveillance for the UK and beyond.
